Healthy VolunteersPhase 4NCT07681076
Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers
A Phase 4 study testing KarXT, Trimethobenzamide and Ondansetron in people with Healthy Volunteers, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 4 sites in United States.
Trial summary
This study looks at how to reduce nausea and vomiting in people taking KarXT which is used to treat mental health conditions like schizophrenia. KarXT can cause stomach-related side effects, especially in the first couple of weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- KarXT, Trimethobenzamide and Ondansetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Sep 2026to 30 Nov 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.
- Participants must be willing and able to be confined to an inpatient setting for a 3-week duration, follow instructions, and comply with the protocol requirements.
- Participants must have BMI ≥ 18 and ≤ 40 kg/m2.
- Individuals of childbearing potential (IOCBP) must be willing and able to adhere to the contraception guidelines.
Who cannot join
- Participants must not have history or presence of clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, gastrointestinal ([GI] eg, obstructive disorders [including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis], active biliary disease [including symptomatic gallstones]), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
- Participants must not have history of moderate to severe alcohol use disorder or a substance (other than nicotine or caffeine) use disorder within the past 12 months or a positive urine drug screen (UDS) for a substance other than cannabis at screening or baseline.
- Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
- Participants must not have active biliary disease (eg, symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the medical monitor.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
United States4 sites, 4 recruiting
- Recruiting
Atlanta Center for Medical Research - CenExel ACMR - PPDS
Atlanta, Georgia, 30331
Elyssa Barron, Site 0001, 404-881-5800
- Recruiting
iResearch Atlanta - CenExel - PPDS
Decatur, Georgia, 30030
Kimball Johnson, Site 0003, 404-537-1281
- Recruiting
CenExel RCA - Hollywood
Hollywood, Florida, 33024-2639
Edwin Gomez, Site 0002, 954-604-3900
- Recruiting
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS
Los Alamitos, California, 90720
David Walling, Site 0004, 714-799-7799
About this study
Official title: A Phase 4, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Twice Daily Xanomeline/Trospium Chloride (KarXT) With Prophylactic and PRN Antiemetic Use in Healthy Volunteers
This study looks at how to reduce nausea and vomiting in people taking KarXT which is used to treat mental health conditions like schizophrenia. KarXT can cause stomach-related side effects, especially in the first couple of weeks. In this study, healthy volunteers will take KarXT along with anti-nausea medication, either regularly (to prevent symptoms) or as needed.
The goal is to see how well these strategies help reduce nausea and vomiting and how safe the combination is. The results will help doctors better manage side effects and make treatment more comfortable for patients starting KarXT.
- Conditions
- Healthy Volunteers
- Being tested
- KarXT, Trimethobenzamide, Ondansetron, Meclizine
- Keywords
- BMS-986510, KarXT, Xanomeline/Trospium, Antiemetics, Nausea, Vomiting, Gastrointestinal side effects
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarXTDrug
Also called Xanomeline/Trospium Chloride, BMS-986510
Specified dose on specified days
TrimethobenzamideDrug
Specified dose on specified days
OndansetronDrug
Specified dose on specified days
MeclizineDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: KarXT; Drug: Trimethobenzamide |
| Arm 2 | Experimental | Not described Receives: Drug: KarXT; Drug: Ondansetron |
| Arm 3 | Experimental | Not described Receives: Drug: KarXT; Drug: Meclizine |
| Arm 4 | Experimental | Not described Receives: Drug: KarXT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Nausea and vomiting
Measured: Up to Day 21
Secondary outcomes (9)
Number of participants with TEAEs
Nausea and vomiting
Measured: Up to Day 14
Time to first onset of nausea and vomiting
Measured: Up to Day 21
Time to resolution of first episode of nausea or vomiting
Measured: Up to Day 21
Number of participants with TEAEs
Measured: Up to Day 28
Number of participants with serious TEAEs
Measured: Up to Day 28
Number of participants with Adverse Events of Special Interests (AESIs)
Measured: Up to Day 28
Number of participants with TEAEs leading to discontinuation
Measured: Up to Day 28
Number of participants with clinically abnormal Vital signs
Measured: Up to Day 28
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start3 Sep 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681076
- Sponsor's protocol ID
- CN012-0182
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html